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Study of Epratuzumab in Systemic Lupus Erythematosus

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00382837
First received: September 29, 2006
Last updated: May 20, 2014
Last verified: March 2007
  Purpose
Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments

Condition Intervention Phase
Systemic Lupus Erythematosus Drug: Epratuzumab Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.

Secondary Outcome Measures:
  • To continue to assess the efficacy and tolerability of epratuzumab;
  • To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
  • To continue to assess epratuzumab on Health-related quality of life in lupus patients;
  • To continue to assess disease status as reported by the patient and physician.

Enrollment: 0
Study Start Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have completed SL0003 Alleviate A through 48 weeks

Exclusion Criteria:

  • Development of toxicity to Epratuzumab
  • Significant protocol deviations from SL0003 Study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382837

  Show 54 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: Anna Barry UCB Pharma
  More Information

ClinicalTrials.gov Identifier: NCT00382837     History of Changes
Other Study ID Numbers: SL0005
EudraCT# 2006-003865-15
Study First Received: September 29, 2006
Last Updated: May 20, 2014

Keywords provided by UCB Pharma:
Lupus,
Antibody,
B-Cell immunotherapy

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 27, 2017